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    Summary
    EudraCT Number:2014-004523-51
    Sponsor's Protocol Code Number:SS0004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-06-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-004523-51
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN?S SYNDROME
    ESTUDIO PRUEBA DE CONCEPTO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE UCB5857 DURANTE 12 SEMANAS EN PACIENTES CON SÍNDROME DE SJÖGREN PRIMARIO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    UCB Proof of Concept Study in patients with Primary Sjogren?s Syndrome
    Estudio de prueba de concepto de UCB en pacientes con síndrome de Sjörgen primario.
    A.4.1Sponsor's protocol code numberSS0004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB Celltech, UK
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUCB Celltech, UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number900 811 335
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUCB5857
    D.3.2Product code UCB5857
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUCB5857
    D.3.9.1CAS number 1362850-20-1
    D.3.9.2Current sponsor codeUCB5857
    D.3.9.3Other descriptive nameUCB5857
    D.3.9.4EV Substance CodeSUB122669
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUCB5857
    D.3.2Product code UCB5857
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUCB5857
    D.3.9.1CAS number 1362850-20-1
    D.3.9.2Current sponsor codeUCB5857
    D.3.9.3Other descriptive nameUCB5857
    D.3.9.4EV Substance CodeSUB122669
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUCB5857
    D.3.2Product code UCB5857
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUCB5857
    D.3.9.1CAS number 1362850-20-1
    D.3.9.2Current sponsor codeUCB5857
    D.3.9.3Other descriptive nameUCB5857
    D.3.9.4EV Substance CodeSUB122669
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Sjogren?s Syndrome
    Síndrome de Sjorgen primario
    E.1.1.1Medical condition in easily understood language
    Primary Sjogren?s Syndrome
    Síndrome de Sjorgen primario
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy on overall disease activity and safety of UCB5857 added to current treatment relative to placebo in subjects with Primary Sjogren?s Syndrome.
    El objetivo principal del estudio es evaluar la eficacia sobre la actividad general de la enfermedad y la seguridad del UCB5857 cuando se añade al tratamiento en curso, comparado con un placebo, en pacientes con SSp.
    E.2.2Secondary objectives of the trial
    1) The efficacy of UCB5857 on changes:
    - in salivary function
    - in tear function
    - patient reported outcomes
    - cost effectiveness
    2)PK profile of UCB5857 in subjects with pSS
    ? La eficacia del UCB5857 con respecto a los cambios en:
    o La actividad salival
    o La actividad lagrimal
    o los resultados según los pacientes
    ? el perfil FC del UCB5857 en pacientes con SSp
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Collection of samples for mRNA and DNA to allow for potential exploratory analyses of transcriptome biomarkers and protein biomarkers relevant to inflammatory and immune response processes or relevant to the mechanism of action of UCB5857
    Recogida de muestras para ARNm y ADN para permitir posibles análisis exploratorios de biomarcadores transcriptómicos y proteicos que resulten relevantes para los procesos de respuesta inflamatoria e inmunitaria o importantes para el mecanismo de acción del UCB5857.
    E.3Principal inclusion criteria
    ?Subject must be between 18 years and 75 years of age
    ?Women of childbearing potential must agree to use an acceptable method of birth control during the study and for a period of 3 months after their final dose of study drug. Women not agreeing to use birth control must be surgically sterile (hysterectomy/oophorectomy or tubal ligation) or postmenopausal for at least 2 years prior to Screening (Visit 1) Women of childbearing potential are required to have a serum pregnancy test taken at Screening (Visit 1), which is confirmed to be negative by urine testing prior to the first dose of study drug at Week 0 (Visit 2)
    ?Subject must meet the 2002 AECG criteria for Primary Sjogren?s Syndrome
    ?Subject must have a serum test positive for anti-SSA/Ro (Ro-52 and Ro-60) and/or anti SSB/La autoantibodies
    ?Subject must have an ESSDAI score of ?5
    ?Subject must have an unstimulated salivary flow rate of > 0mL/5 minutes
    *El paciente deberá tener entre 18 y 75 años de edad.
    *Las mujeres con capacidad de quedarse embarazadas deberán aceptar el uso de un método aceptable de control de la natalidad durante el estudio y en los tres meses posteriores a su última dosis del medicamento del estudio. Se consideran métodos aceptables de control de natalidad los anticonceptivos orales (que deberán tomarse de manera ininterrumpida durante un mes entero antes de la selección [visita 1], y deberán seguir tomándose ininterrumpidamente durante el estudio), métodos de doble abarrera, y métodos de barrera simple con diafragma que incluya espermicida o preservativo con espermicida. Las mujeres que no acepten utilizar métodos de control de natalidad deberán estar esterilizadas quirúrgicamente (histerectomía/ooforectomía o ligadura de trompas) o ser postmenopáusicas desde al menos dos años antes del momento de la selección (visita 1). Las mujeres con capacidad de quedarse embarazadas deberán someterse a una prueba de embarazo en suero en la selección (visita 1), que se confirmará como negativa mediante una prueba de embarazo en orina antes de recibir la primera dosis del medicamento del estudio en la semana 0 (visita 2).
    *Los pacientes deberán cumplir los criterios AECG 2002 para SSp
    *El paciente deberá haber dado seropositivo para los autoanticuerpos anti-SSA/Ro (Ro-52 y Ro-60) y/o anti-SSB/La.
    *El paciente deberá tener un valor ESSDAI ?5.
    *El paciente deberá presentar una producción salival sin estimulación > 0 ml/5 minutos.
    E.4Principal exclusion criteria
    ?Subject has a diagnosis of any other autoimmune disease, ie, secondary Sjögren?s syndrome (eg, rheumatoid arthritis, systemic lupus erythematosus)
    ?Subject has a diagnosis of any other sicca syndrome (eg, history of head and neck radiation treatment, sarcoidosis chronic graft-versus-host disease)
    ?Subject has, in the opinion of the Investigator, significant fibromyalgia syndrome
    ?Subject has, in the opinion of the Investigator, significant depression
    ?Subject has oral candidiasis
    ?Subject is female and is breast-feeding, pregnant, or plans to become pregnant or to start breastfeeding during the study or within 3 months after the final dose of the investigational medicinal product (IMP)
    ?Subject has evidence of an immunosuppressive state, including human immunodeficiency virus (HIV) infection, hypogammaglobulinemias, T-cell deficiencies, or human T-cell leukemia virus type 1 (HTLV-1)
    ?Subject has a history of chronic infections, including but not limited to concurrent acute or chronic viral hepatitis B or C. A subject with a history of a recent serious or life-threatening infection or any current signs or symptoms that may indicate a significant infection at Screening (Visit 1) to randomization, as per the Investigator?s clinical judgment is also excluded. Subject must have completed any prior anti-infective therapy prior to the first dose of study drug with the exception of anti-infectives taken specifically for the treatment of acne, rosacea, onychomycosis, or vaginal yeast infections; for the prophylaxis of urinary tract infections; or prophylaxis for pre-surgical or pre-procedural reasons (including dental procedures). Note: minocycline may not be used for these purposes
    ?Subject is, in the opinion of the Investigator, at a particularly high risk of significant infection due to their lifestyle and/or occupation
    ?Subject has received intranasal influenza vaccine within the 8 weeks prior to Screening (Visit 1)
    ?Subject has significant hematologic abnormalities of hemoglobin <8.0g/dL, or white blood cell (WBC) <2000/mm3, or absolute neutrophil count <1000/mm3, or platelets <30,000/mm3 at Screening (Visit 1)
    ?Subject has a history of cancer, except the following treated cancers: Sjögren?s syndrome associated lymphoma, cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
    *Al paciente se le ha diagnosticado cualquier otra enfermedad autoinmunitaria, es decir, síndrome de Sjögren secundario (por ejemplo: artritis reumatoide o lupus eritematoso sistémico).
    *Al paciente se le ha diagnosticado cualquier otro síndrome seco (por ejemplo, antecedentes de radioterapia otorrinolaringológica, sarcoidosis crónica, rechazo inverso de injertos).
    *El paciente presenta, en opinión del investigador, un síndrome fibromiálgico considerable.
    *El paciente presenta, en opinión del investigador, una depresión considerable.
    *El paciente padece candidiasis bucal
    *La paciente es mujer y está amamantando, está embarazada o prevé quedarse embarazada o empezar a dar el pecho durante el estudio, o en los 3 meses posteriores a recibir la última dosis del medicamento experimental (ME).
    *La paciente muestra signos de inmunodepresión, como infección por el virus de la inmunodeficiencia humana (VIH), hipogammaglobulinemias, deficiencias de células T, o infección por el virus T-linfotrópico humano tipo I (VTLH-I).
    *El paciente presenta antecedentes de infecciones crónicas, entre otras, hepatitis B o C vírica crónica o aguda de manera concurrente. Los pacientes con antecedentes de una infección grave o potencialmente mortal reciente, o que en la actualidad presenten cualquier signo o síntoma que indique una infección significativa en el momento de la selección (visita 1) hasta la aleatorización en la visita 2, según el criterio clínico del investigador, también quedarán excluidos. El paciente deberá haber completado cualquier tratamiento antiinfeccioso previo antes de recibir la primera dosis del medicamento del estudio, excepto los fármacos antiinfecciosos que se tomen específicamente para el tratamiento del acné, acné rosácea, onicomicosis o infecciones vaginales por hongos levaduriformes; para la profilaxis de infecciones del aparato urinario; o para profilaxis prequirúrgica o previa a una intervención (inclusive intervenciones odontológicas). Nota: no deberá utilizarse minociclina para estos fines.
    *El paciente está, en opinión del investigador, en riesgo especialmente alto de infección considerable a causa de su estilo de vida o actividad laboral.
    *El paciente ha recibido una vacuna antigripal intranasal en las 8 semanas antes de la selección (visita 1).
    *El paciente presenta anomalías sanguíneas significativas como hemoglobina <8,0 g/dl, o leucocitos <2000/mm3, o recuento total de neutrófilos <1000/mm3, o de plaquetas <30.000/mm3 en la selección (visita 1).
    *El paciente tiene antecedentes de cáncer, excepto los cánceres tratados siguientes: Linfoma asociado al síndrome de Sjögren, carcinoma cervicouterino preinvasor, carcinoma basocelular, carcinoma dérmico de células escamosas.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline in the European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI)
    Cambio en el ESSDAI desde el valor de partida
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    1) Change from Baseline in the European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI)
    2) Change from Baseline in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
    3) Change from Baseline in the stimulated salivary flow
    4)Change from Baseline in the unstimulated salivary flow
    5)Change from Baseline in Schirmer I test (without anesthesia)
    1) Cambio en el ESSDAI desde el valor de referencia.
    2) Cambio en ESSPRI desde la situación inicial
    3) Cambio en la producción salival, con estimulación
    4) Cambio en la producción salival, sin estimulación
    5) Cambio en la secreción lagrimal según la prueba I de Schirmer (sin anestesia)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Week 4 and 8
    2) Week 4, 8 and 12
    3) Week 4, 8 and 12
    4) Week 4, 8 and 12
    5) Week 12
    1) Semanas 4 y 8
    2) Semanas 4, 8 y 12
    3) Semanas 4, 8 y 12
    4) Semanas 4, 8 y 12
    5) Semana 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 58
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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